WEDNESDAY, OCTOBER 25
DINNER | 6:15 – 9:15 PM
SC6: Strategic/Modular Bioassay Design and Analysis
David Lansky, Ph.D., President, Precision Bioassay, Inc.
When bioassays are used to estimate the potency of test lots from samples, attention is focused on the properties of reportable values (typically geometric mean potencies from replicate assays, which are compared to product specifications as part of lot acceptance). Good management of production processes and analytic methods includes process control limits for log potency well inside product specifications. A similar approach should be used for assay and sample acceptance criteria, with assay performance measures having control limits that assure that reported values easily meet performance requirements for the assay. Review of what is known about bioassays (how they are both inherently robust and non-robust) yields good choices of targets for assay development and properties of bioassays to use for assay acceptance and monitoring. Modular design (and appropriate analyses) support efficient and flexible procedures for development, qualification, validation (including robustness testing), transfer, and monitoring as well as supporting easy tuning of assay performance properties of reported values for various intended uses.
David Lansky’s training includes both biology (BS in Botany from San Francisco State and MS in Entomology from Cornell) and statistics (MS and PhD in Biometry from Cornell). David has been practicing statistical design and analysis of biological assays for over 30 years. He had a substantial role in the development of the USP bioassay chapters (<103X>) and currently leads a subcommittee that is working on revisions to those chapters.